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Condition 1 - Educational Condition (Educational Book Group)NCT02203617

Using Baby Books to Promote Maternal and Child Health

A study testing Educational Content/Pediatric Anticipatory Guidance and Book provision in people with Condition 1 - Educational Condition (Educational Book Group) and Condition 2 - Non-educational Condition (Non-educational Book Group), run by Vanderbilt University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Baby Books Project tests whether embedding educational information into baby books can improve the health and wellbeing of first-time mothers and their young children. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
What is being tested?
Educational Content/Pediatric Anticipatory Guidance and Book provision
Could I receive a placebo?
No, everyone receives an active treatment
How many people
198 participants
Where
2 sitesUnited States
Study dates
Apr 2005to Jul 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Women who are pregnant with first child and able to read in English at a first grade reading level

Who cannot join

  • Women with other children, men, those not able to read in English at a first grade level

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of California, Irvine

    Irvine, California, 92697

  • Vanderbilt University

    Nashville, Tennessee, 37212

Other trials in United States

About this study

The Baby Books Project tests whether embedding educational information into baby books can improve the health and wellbeing of first-time mothers and their young children.

Read the detailed description

This study tests the efficacy of embedding educational information (i.e., pediatric anticipatory guidance) into baby books that first-time mothers read to their infants. This 3-group longitudinal study recruited first-time mothers in their third trimester of pregnancy, randomly assigned them to conditions, and followed them until the child was 18 months of age. One group received educational baby books, another group was given the same illustrated books with non-educational text, and the third group was not given any books. Thus, the effects of educational reading could be parsed from the effects of reading alone. The study aimed to test whether embedding pediatric anticipatory guidance in picture books is an effective method for increasing maternal knowledge of child development, parenting strategies, and safety practices, improving parenting beliefs and attitudes (e.g., parenting efficacy, importance of reading, use of corporal punishment), supporting optimal parenting practices (e.g., breastfeeding and nutrition, responsiveness, safety practices), improving maternal health (stress, depression), and supporting children's healthier development (injuries, illness, immunizations, and linguistic, social, and cognitive development).

Survey and observational data collection occurred in participants' homes during their third trimester of pregnancy and when their child was 2, 4, 6, 9, 12, and 18 months of age. Twelve phone call interviews were conducted between these home visits. When children were 18 months, a retrospective medical chart audit was conducted.

Being tested
Educational Content/Pediatric Anticipatory Guidance, Book provision
Keywords
anticipatory guidance, baby books, safety

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational Content/Pediatric Anticipatory GuidanceBehavioural

    educational information from Bright Futures Guidelines for Health Supervision for birth to 18 months

  • Book provisionBehavioural

    Given free books prenatally and at 2, 4, 6, 9, 12, and 18 months postpartum

Study groups in NCT02203617
Study groupRoleWhat they receive
educational baby booksExperimentalbooks embedded with educational information (pediatric anticipatory guidance)
Receives: Behavioral: Educational Content/Pediatric Anticipatory Guidance; Behavioral: Book provision
non-educational baby booksActive comparatorbaby books given with same illustrations but no educational information
Receives: Behavioral: Book provision
no booksNo interventionnot given any baby books

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in knowledge of child development and parenting

    Measured with Opinions about Babies questionnaire

    Measured: Change from Baseline (pregnancy) to 18 months postpartum

  2. Change in Reading Practices

    Self-reported joint reading practices

    Measured: Change from 2 to 18 months postpartum

  3. Parenting Stress

    Measured with the Parenting Stress Index

    Measured: Change from 2 to 18 months post-partum

  4. Costs

    Maternal costs due to their own and their child's illness/injury, use of substances, and purchase of food was measured with the Incurred Cost Questionnaire.

    Measured: Cumulative costs over study duration

Secondary outcomes (17)

  1. Safety Practices

    Measured with the Home Safety Assessment, an observational and self-report measure of safety practices in the home, car, and outside

    Measured: 2, 4, 6, 9, 12, and 18 months postpartum

  2. Attitudes about Corporal punishment

    Adolescent-Adult Parenting Inventory

    Measured: 2, 6, 12 and 18 months postpartum

  3. Maternal Depressive Symptoms

    Depressive symptoms were measured with the Center for Epidemiologic Studies Depression Scale.

    Measured: Change from baseline (pregnancy) to 18 months postpartum

  4. Beliefs about the Importance of Reading to Children

    Maternal beliefs about the importance of reading was measured with the Modified Parent Reading Belief Inventory

    Measured: Change from baseline (prenatal) to 18 months postpartum

  5. Injuries and illnesses

    Child illnesses injuries were measured with the Incurred Cost Questionnaire and through a retrospective medical chart audit.

    Measured: 16 months (from 2 to 18 months postpartum)

  6. Quality of Parent-Child Interaction

    Video recording and in-vivo coding of mother-child dyads during play and reading.

    Measured: Change from 2 to 18 months postpartum

  7. Home environment and parenting

    measured with the Home Observation for Measurement of Environment (HOME).

    Measured: Change from 2 to 18 months postpartum

  8. Receptive and Expressive language

    Measured with the Preschool Language Scale - Fourth Edition (PLS4).

    Measured: Change from 6 to 18 months postpartum

  9. Cognitive and neurological development screening

    Measured with the Bayley Infant Neurodevelopmental Screener (BINS)

    Measured: 4, 6, 9 months postpartum

  10. Infant nutrition

    Infant Nutrition Interview measured the introduction of news foods, types of foods, and serving portions at each time point.

    Measured: 2, 4, 6, 9, 12, and 18 months postpartum

  11. Breastfeeding intentions and practices

    measured with the Breastfeeding Intentions and Practices Scale

    Measured: prenatal and postnatal every visit until no longer breastfeeding

  12. Pregnancy uplifts and Hassles

    measured with the Pregnancy Experience Scale

    Measured: Baselines (pregnancy)

  13. Parenting Satisfaction

    measured with the Parenting Satisfaction Scale

    Measured: Change from 2 to 18 months postpartum

  14. Parenting Self-Efficacy

    Measured with the Maternal Self-Efficacy Scale

    Measured: Change from 2 to 18 months postpartum

  15. Reading self-efficacy

    measured with the Reading Self-Efficacy Scale

    Measured: Change from 2 to 18 months postpartum

  16. Cognitive Development

    measured with Exploratory Play Task

    Measured: 12 and 18 months postpartum

  17. Immunizations, medical visits, and growth status

    measured through a retrospective medical chart audit.

    Measured: 18 months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2014 (estimated)
  2. Study startApr 2005
  3. Primary completionJun 2009
  4. Study completionJul 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
198 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02203617
Sponsor's protocol ID
R01HD447749
Status last verified
Apr 2017
First submitted
18 Jul 2014
Last updated
14 Apr 2017
Results posted
No
Data monitoring committee
No

Publications

  • Khalessi A, Reich SM. A Month of Breastfeeding Associated with Greater Adherence to Pediatric Nutrition Guidelines. J Reprod Infant Psychol. 2013 Jul 1;31(3):299-308. doi: 10.1080/02646838.2013.784898.

    PubMed 24062596

  • Reich SM, Penner EK, Duncan GJ, Auger A. Using baby books to change new mothers' attitudes about corporal punishment. Child Abuse Negl. 2012 Feb;36(2):108-17. doi: 10.1016/j.chiabu.2011.09.017. Epub 2012 Mar 3.

    PubMed 22391417

  • Reich SM, Penner EK, Duncan GJ. Using baby books to increase new mothers' safety practices. Acad Pediatr. 2011 Jan-Feb;11(1):34-43. doi: 10.1016/j.acap.2010.12.006.

    PubMed 21272822

  • Reich SM, Bickman L, Saville BR, Alvarez J. The effectiveness of baby books for providing pediatric anticipatory guidance to new mothers. Pediatrics. 2010 May;125(5):997-1002. doi: 10.1542/peds.2009-2728. Epub 2010 Apr 12.

    PubMed 20385630

Questions about this trial

What is this clinical trial studying?

A study testing Educational Content/Pediatric Anticipatory Guidance and Book provision in people with Condition 1 - Educational Condition (Educational Book Group) and Condition 2 - Non-educational Condition (Non-educational Book Group), run by Vanderbilt University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in knowledge of child development and parenting (time frame: Change from Baseline (pregnancy) to 18 months postpartum). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02203617, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2017.

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